A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults
Phase 1
Completed
- Conditions
- Chronic Hepatitis B
- Interventions
- Drug: ABI-H3733 Solid Oral Dosage FormDrug: Placebo to ABI-H3733 Solid Oral Dosage FormDrug: ABI-H3733 Liquid Oral Dosage FormDrug: Placebo to ABI-H3733 Liquid Oral Dosage Form
- Registration Number
- NCT04271592
- Lead Sponsor
- Assembly Biosciences
- Brief Summary
This study is designed to assess safety, tolerability, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1 includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending dose (SAD) and multiple-ascending dose (MAD) administration of the oral liquid formulation. Part 2 includes assessment of a solid dosage formulation of ABI-H3733 in participants under fasted conditions or after a high-fat meal. Optional cohorts may be enrolled in Parts 1 and 2 of the study to explore additional dose levels, solid oral dosage formulations, or for cohort expansion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.
Exclusion Criteria
- Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
- History of or current persistent drug or alcohol abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2: Single Dose Fasted Cohort 11 ABI-H3733 Solid Form ABI-H3733 Solid Oral Dosage Form A single dose of ABI-H3733 solid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. Part 2: Single Dose Fasted Cohort 11 Placebo Solid Form Placebo to ABI-H3733 Solid Oral Dosage Form A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. Part 2: Single Dose Fed Cohort 12 ABI-H3733 Solid Form ABI-H3733 Solid Oral Dosage Form A single dose of ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. Part 2: Single Dose Fed Cohort 12 Placebo Solid Form Placebo to ABI-H3733 Solid Oral Dosage Form A single dose of placebo matching ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. Part 1: SAD Cohorts 1-7 ABI-H3733 Liquid Form ABI-H3733 Liquid Oral Dosage Form A single dose of ABI-H3733 liquid oral dosage form administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. Part 1: SAD Cohorts 1-7 Placebo Liquid Form Placebo to ABI-H3733 Liquid Oral Dosage Form A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. Part 1: MAD Cohorts 8-10 ABI-H3733 Liquid Form ABI-H3733 Liquid Oral Dosage Form Once-daily doses of ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. Part 1: MAD Cohorts 8-10 Placebo Liquid Form Placebo to ABI-H3733 Liquid Oral Dosage Form Once-daily doses of placebo matching ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts.
- Primary Outcome Measures
Name Time Method Number of Participants with One or More Adverse Events Up to Day 10 Number of Participants with One or More Related Adverse Events Up to Day 10 Number of Participants with One or More Severe (Grade ≥3) Adverse Events Up to Day 10
- Secondary Outcome Measures
Name Time Method SAD Cohorts 1-7: Time of Cmax (Tmax) of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing SAD Cohorts 1-7: Apparent Terminal Elimination Half-life (t1/2) of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing MAD Cohorts 8-10: AUC of ABI-H3733 before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5 SAD Cohorts 1-7: Maximum Plasma Concentration (Cmax) ABI-H3733 before and at pre-specified time points up to 120 hours after dosing MAD Cohorts 8-10: Cmax Over the Dosing Interval of ABI-H3733 before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5 SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing MAD Cohorts 8-10: Tmax of ABI-H3733 before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5 MAD Cohorts 8-10: t1/2 of ABI-H3733 before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5 Single Dose Cohorts 11-12: AUC of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing Single Dose Cohorts 11-12: Cmax of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing Single Dose Cohorts 11-12: Tmax of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing Single Dose Cohorts 11-12: t1/2 of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing
Trial Locations
- Locations (1)
Auckland Clinical Studies
🇳🇿Auckland, New Zealand